CataractNCT03579433

Postmarket Study of an Intraocular Lens Power Selection System

A study testing ORA with VerifEye+, Alcon Barrett Toric Calculator and Acrysof® IQ Toric IOL in people with Cataract, run by Alcon Research at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract
What is being tested?: ORA with VerifEye+, Alcon Barrett Toric Calculator and Acrysof® IQ Toric IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 9 sitesUnited States
Study dates: 16 Aug 2018to 16 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Planned cataract surgery with IOL implantation
Able to comprehend and sign the informed consent form
Preoperative astigmatism of 0.75 to 3.00 Diopter
Willing and able to complete all required postoperative visits
Other protocol-defined inclusion criteria may apply

Who cannot join

Unclear intraocular media other than cataract
Pregnant or lactating
Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
Other protocol-defined exclusion criteria may apply

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Alcon Investigative Site
Florence, South Carolina, 29501
Alcon Investigative Site
Kingston, Pennsylvania, 18704
Alcon Investigative Site
Mt. Dora, Florida, 32757
Alcon Investigative Site
Mt. Pleasant, South Carolina, 29464
Alcon Investigative Site
Nacogdoches, Texas, 75965
Alcon Investigative Site
Nashville, Tennessee, 37205
Alcon Investigative Site
Panama City, Florida, 32405
Alcon Investigative Site
Poughkeepsie, New York, 12603
Alcon Investigative Site
Sioux Falls, South Dakota, 57108

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About this study

Official title: Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric

Read the detailed description

Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Conditions: Cataract
Being tested: ORA with VerifEye+, Alcon Barrett Toric Calculator, Acrysof® IQ Toric IOL
Keywords: IOL, Intraocular lens, Astigmatism, Cataract Surgery
Medical subject headings: Cataract, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ORA with VerifEye+Device
Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.
Alcon Barrett Toric CalculatorOther
Web-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.
Acrysof® IQ Toric IOLDevice
Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)

Study groups in NCT03579433
Study group	Role	What they receive
ORA with VerifEye+	Experimental	First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group. Receives: Device: ORA with VerifEye+; Device: Acrysof® IQ Toric IOL
Barrett Toric Calculator	Active comparator	First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group. Receives: Other: Alcon Barrett Toric Calculator; Device: Acrysof® IQ Toric IOL

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 201816 Apr 2019

First posted6 Jul 2018
Study start16 Aug 2018
Primary completion16 Apr 2019
Study completion16 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03579433
Sponsor's protocol ID: ILX369-P001
Status last verified: Apr 2020
First submitted: 26 Jun 2018
Last updated: 7 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric
ClinicalTrials.gov ID: NCT03579433
Acronym / sponsor ID: ILX369-P001
Conditions: Cataract
Keywords: IOL, Intraocular lens, Astigmatism, Cataract Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 16 Aug 2018 (actual)
Primary completion: 16 Apr 2019 (actual)
Study completion: 16 Apr 2019 (actual)
First posted: 6 Jul 2018 (actual)
Results: Posted 7 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ORA with VerifEye+	Experimental	Device: ORA with VerifEye+, Device: Acrysof® IQ Toric IOLFirst surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
Barrett Toric Calculator	Active comparator	Other: Alcon Barrett Toric Calculator, Device: Acrysof® IQ Toric IOLFirst surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Planned cataract surgery with IOL implantation
Able to comprehend and sign the informed consent form
Preoperative astigmatism of 0.75 to 3.00 Diopter
Willing and able to complete all required postoperative visits
Other protocol-defined inclusion criteria may apply

Key exclusion criteria (4 listed)

Unclear intraocular media other than cataract
Pregnant or lactating
Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
Other protocol-defined exclusion criteria may apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ORA with VerifEye+Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.	Device	ORA with VerifEye+
Alcon Barrett Toric CalculatorWeb-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.	Other	Barrett Toric Calculator
Acrysof® IQ Toric IOLIntraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)	Device	Barrett Toric Calculator, ORA with VerifEye+

Primary outcome

Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
Time frame: Month 6
Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.

Results and safety

Results posted to the registry on 7 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	104	98

Primary outcome: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6

Time frame: Month 6. Number. Unit: percentage of eyes

Measure	ORA With VerifEye+ n = 85	Barrett Toric Calculator n = 95
Value	87.1	87.4

Population analysed: The Per Protocol Analysis Set (PPS) includes all eyes with successful IOL implantation, T3-T6 and recommended by ORA and with no major protocol deviations and data at visit.

Adverse events

Time frame: Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 104 (0%)	0 of 104 (0%)	0 of 104
ORA With VerifEye+ Study Eye	2 of 96 (2.1%)	10 of 96 (10.4%)	0 of 96
Barrett Toric Calculator Study Eye	2 of 102 (2%)	7 of 102 (6.9%)	0 of 102
Overall Systemic	1 of 104 (1%)	0 of 104 (0%)	0 of 104

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Operations Lead, Surgical study director

Alcon Research, LLC

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ORA with VerifEye+, Alcon Barrett Toric Calculator and Acrysof® IQ Toric IOL in people with Cataract, run by Alcon Research at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.